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DiaCeph Description

 

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DIACEPH CNS SHUNT MONITORING SYSTEM: Test Description

This test is intended for patients who are conscious and four (4) years of age through late senior who can respond and answer queries, similar to a physician interview and cooperation required of a standard hearing test. Test reliability becomes standardized to each patient with on-going use. We have authored a new tandem DiaCeph/single in-office shunt tap protocol which verifies the accuracy of DiaCeph data, and broadens the information possible through a single shunt tap. DiaCeph Testing is intended to further the diagnostic work-up of shunt malfunction, pre-surgical shunt selection, calibration of programmable shunts, NPH work-ups, and post discharge monitoring of both shunted and ETV'd patients. DiaCeph's AI software and algorithms (SEE PDF file at right) form the foundation for monitoring, via overlays of incident data to earlier baseline data, and corroboration with clinical symptoms and in-office ICP taps. DiaCeph monitoring is higher in sensitivity and specificity than CT, MRI, isotope clearance, or ICP taps alone.

The PDA device is designed for downloading data to a DiaCeph PC program, where it can be emailed or posted to a web site, or uploaded through a telephone system. Test results include comparative graphs of shunt patency, relative ICP, individual parameters, and post interventional testing. Testing is best done at set times during the day, typically 4 to 8 samples per day. Incident samplings and episodic samplings employing predetermined "interventions" may be used to evaluate complex shunt malfunction in real time. Data is plotted on Time v. Value graphs to provide visual displays of shunt performance. A database of findings of various shunt systems could be quite useful. The effect of its overall capabilities enables it to function as both a diagnostic device, and an advanced disease management program by archiving detailed shunt performance and patient status information over a long period of time.

Description of the DiaCeph Test:

The DiaCeph Test's principal components are a stand alone PDA or mobile telephone embedded with its operating program, a PC software program for processing and display, Internet service or mobile phone plan, a USB interface, and user instructions. The program comes in a menu format, where the user is prompted and instructed how to perform each step, and the unit performs simultaneous tracking of each input selection. The user initially establishes a patient profile, including shunt type and cognitive test defaults, and may enter personal health information. The user, upon the direction of the physician, may change certain parameters to best suit a given patient.

DiaCeph Test Features and Benefits:

  Portable, User Friendly Menu Prompts                            Standard and Advanced Testing

  Results Available at Touch of a Button                            Single or Pre-set Serial Sampling

  Up to Date Cognitive Assessment Tests                           Results Sent to PC and/or Internet

  Contraindications Warning Alert                                      Prints Time  vs. Parameter Graphs

  Accommodates a Variety of Patient                                 Maintains Patient Profiles

  Provides Estimate of Relative ICP                                    Increases Access to Medical Care

  High Level of Sensitivity to Malfunction                          Reduces Needless Doctor/ER Visits

  Helps Manage Daily Schedules                                       Assessment of Shunt Patency

NEW: Tandem Application with a Single In-Office ICP Shunt Tap

Sample Collection:

To collect a sample, the user would select either the Standard, Advanced, Pre-Set Timed, or Interventional protocol. The auto-program then prompts the user to select the patient's Activity that preceded the sample by selecting it from a list of activities that appear on the screen. Next, it prompts the user with instructions to determine the patient's level of Nausea, and select it on the display screen using a scoring system of N to 3, where "N" = normal, and "3" = most severe. Next, identify the level of Headache in the same manner by identifying the respective level on the display screen. Continue with the remainder of the parameters. When prompted to perform the Cognitive Test, follow the on-screen instructions and identify the score.

Follow the instructions in performing the Positional Test, and identify the findings with the patient in the Supine posture, and then in the Upright posture. The program will store the results in the patient's "Journal" file. Follow the prompt instructions in making an observation of the patient's shunt system, and select the findings from the list on the display screen. Perform an assessment of Proximal Patency, if applicable, or as instructed by the treating physician. Follow the prompt instructions and repeat the same for the remainder of the parameters.

Test results are stored in a Journal file and later on PC disks. To obtain results, place the PDA in the cradle and downloaded the data to the DiaCeph PC program (or internet site) for review and display. The PDA may display results albeit a physician key code. The PDA program processes the data and compares test results to a list of fourteen (14) possible shunt malfunctions/outcomes. The program then recommends Interventions (if needed) based on test findings and in conjunction with the physician to better evaluate complex malfunctions.

Below, are Seventeen (17) Interventions Available through Advanced Testing:

  1. Lay Down (Rest)
  2. Lay Down (Trendelenburg)
  3. Exercise and Straining
  4. Assume Upright Posture
  5. Bend Over at Waist with Head Down
  6. Use Finger or Other Means to Stop/Reduce CSF Flow thru Distal Catheter
  7. Use of Elastic Wrap Around Abdomen
  8. Manipulation of Abdomen and Distal End of Shunt Catheter
  9. Lower External Body/Shunt Pressure: Trip to Mountains/Barometric Chamber
  10. Raise External Body/Shunt Pressure: Submerge under Water/Barometric Chamber
  11. Percutaneous Flushing and/or Vibration Maneuver over Shunt Valve
  12. Lift and Loosen Scalp Over ASD /SCD Shunt
  13. Change Pillow and Pressure Over ASD /SCD Shunt
  14. Diamox Prescription Intervention and/or Therapy
  15. Palliative Medicines and Interventions
  16. Biofeedback, Stress Reduction, Visualization Techniques
  17. New Tandem Monitoring with ShuntCheck Test, ICP Tap, Isotope Clearance, and other Shunt Flow Testing

Test parameters in the DiaCeph Test are well recognized in field study and hydrocephalus treatment. Test sensitivity and specificity has been corroborated in radiographs and surgical findings in a few trials by Stephen Dolle, its inventor. His 1998 Clinical Trial was effective in identifying anti-siphon functional obstructions, proximal and distal shunt obstruction, shunt dependency, and helped in managing of daily complaints and quality of life.

Below, Shunt Malfunctions/Outcomes A - N are Matched to Test Data:

A. Proximal Catheter/Valve Obstruction

B. Proximal Obstruction w/ Collapsed Vent.

C.  Proximal Disconnect of Components

D.  Infection w/ Proximal Valve Obstruction

E.  NORMAL System Function

F.  NORMAL Function w/ CSF Underdrainage

G.  Shunt Overdrainage/Hypotension (incl. ASDs)

H.  ASD Shunt Overfunction w/ Underdrainage

I.    Distal Catheter/Valve Obstruction

J.   Mal-Positioned Distal Catheter

K.  Distal Disconnect of Components

L.   Infection w/ Distal Obstruction

M.  Other Pathology/Seizure Activity

N.  Decompensated Hydrocephalus

Results and Display:

DiaCeph results are available on the unit display, and on hard copy after downloading to PC. After downloading to PC, data is plotted as Time v. Parameter Values graphs as noted below:

1.  Graph of shunt patency values with overlay to baseline

2.  Graph of relative ICP values with overlay to baseline

3.  Graph of individual parameters with overlay to baseline

4.  Graph of cognitive values with overlay to baseline

5.  Graph of interventional data with overlay to prior samplings

6.  Display of most probable malfunction(s) from list of 14 possible

7.  Display of relative ICP values for each monitoring point

8.  Display of shunt patency values of proximal, distal, and refill scoring

Processing Algorithms:

1. Algorithm determines relative ICP from the following parameter values:

nausea score

headache score

malaise, eye signs, or balance score

cognitive score

positional test score

2. Algorithm determines shunt patency from the following parameter values:

nausea score

headache score

malaise, eye signs, or balance score

relative ICP score

percutaneous finger assessment of patency